Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
This recall has been terminated (originally issued July 17, 2013).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- June 19, 2013
- Posted
- July 17, 2013
- Terminated
- November 4, 2014
- Recall Number
- Z-1749-2013
- Quantity
- S099: 171,587 units and S099B: 505,107 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
Distribution
Worldwide Distribution - USA (nationwide) and Canada.
Lot / Code Info
Models S099 and S099B
Root Cause
Component design/selection
Action Taken
Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.